BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIANCE FN

    MDR report key: 500671 · Received December 8, 2003

    Report

    Report Number
    2135225-2003-00006
    Event Type
    Other
    Date Received
    December 8, 2003
    Date of Event
    January 1, 2003
    Report Date
    December 8, 2003
    Manufacturer
    BIOFORM, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS "UNIQUE COMPLICATIONS FROM RADIANCE." PATIENT HAD TWO BIOPSIES ON THEIR NECK WHICH TURNED OUT TO BE RADIANCE. PATIENT ALSO HAS A LUMPY AREA ON THEIR NECK THAT WILL REQUIRE SURGERY. THE PATIENT KNOWS WHERE THE RADIANCE WAS INJECTED, BECAUSE PATIENT COULD FEEL IT. THE PATIENT ALSO STATED THAT THE RADIANCE BEGAN TO MIGRATE MONTHS POST INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIANCE FN INJECTABLE IMPLANT LMH BIOFORM, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other